MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH 930 ANALYZER

Model Number	ATELLICA CH 930 ANALYZER
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens healthcare diagnostics customer care center (ccc) regarding erroneously elevated carbon dioxide, concentrated (co2_c) result obtained on a patient sample on an atellica ch 930 analyzer.Siemens reviewed the instrument data and observed particulates in the reaction bath, reaction kinetics indicated possible droplets from the reaction wash station.The customer service engineer (cse) was dispatched to the customer's site.During the visit the cse replaced wash probe (wp1) valve, light engine, lamp, reaction wash basin, light engine, reagent probe 1, level sense board, and level sense cable and realigned reagent probe 1, ran all alignments and auto check, observed damage in the probe and level sense problem on the same board which allowed liquid to get to the board, ran patient comparison quality control (pcqc) test for the reaction ring height adjustment, cleaned reaction bath, encountered vertical collision errors with reagent probe 1, ran daily quality control (qc) and calibration, which passed.Siemens evaluated the event and determined that an instrument malfunction, which was addressed with the service activities, potentially contributed to the erroneously elevated co2_c result.The cause of the event is could not be determined.The device is performing within specifications.No further evaluation is required.
Event or Problem Description
The customer reported an erroneously elevated carbon dioxide, concentrated (co2_c) result was obtained on a patient sample on an atellica ch 930 analyzer.The erroneous result was reported to the physician(s) and was questioned.The same sample was repeated on an alternate atellica ch analyzer.The repeat result was considered correct and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the erroneously elevated carbon dioxide, concentrated (co2_c) result.

• Brand Name: ATELLICA CH 930 ANALYZER
• Common Device Name: ATELLICA CH 930 ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown; NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; registration #: 2247117; 62 flanders bartley rd; flanders NJ 07836
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 24480734
• Report Number: 2432235-2026-00064
• Device Sequence Number: 10277772
• Product Code: JJE
• UDI-Device Identifier: 00630414002163
• UDI-Public: (01)00630414002163
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K151767
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ATELLICA CH 930 ANALYZER
• Device Catalogue Number: 11067000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown